A Study in Male and Female Subjects With Androgenetic Alopecia Treated With ATI-50002 Topical Solution

Aclaris Therapeutics

Status and phase: Completed; Phase 2

Conditions: Androgenetic Alopecia

Treatments: Drug: ATI-50002

Study type: Interventional

Funder types: Industry

Identifiers

NCT03495817

ATI-50002-AGA-201

Details and patient eligibility

About

Open label study to assess safety, tolerability, and efficacy of ATI-50002 in male and female subjects with androgenetic alopecia.

Full description

This is an open-label study designed to evaluate the safety and efficacy of ATI-50002 Topical Solution in male and female subjects with androgenetic alopecia.

Enrollment: 31 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Male subjects and non-pregnant, non-nursing female subjects 18-50 years of age with a clinical diagnosis of androgenetic alopecia.

Subjects willing to agree to have a small circle of hair clipped to approx. 1mm in length on their balding spot.

Subjects willing to agree to have a permanent dot tattoo applied to their scalp to mark the center of the identified target area.

Subjects must agree to maintain the same hair style and hair care regimen during the study.

Exclusion criteria

Females who are nursing, pregnant, or planning to become pregnant for the duration of the study and up to 30 days after the last application of study medication.

Clinical diagnosis of alopecia areata or other non AGA forms of alopecia. Scalp hair loss on the treatment area, due to disease, injury or medical therapy.

Active skin disease of the scalp (such as psoriasis or seborrheic dermatitis) or a history of skin disease on the scalp that in the opinion of the investigator would interfere with the study assessments or efficacy or safety.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

ATI-50002 Topical Solution

Experimental group

Description:

This is an open-label phase 2 study designed to evaluate the safety and efficacy of ATI- 50002 Topical Solution, 0.46% in male and female subjects with androgenetic alopecia. Subjects will be required to apply ATI-50002 study medication to their scalp twice a day for a total of 26 weeks.

Treatment:

Drug: ATI-50002